BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4231896 · Received October 17, 2014

    Report

    Report Number
    3008642652-2014-03389
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING WITH SERVICE CODE 203. UPON EVALUATION, THERE WERE BROKEN SOLDER CONNECTIONS AT THE U900 (ANALOG MUX) AND U901 (QUAD MICROPOWER OP AMP) COMPONENTS ON THE MONITOR C/A BOARD. THE CAUSE OF THE INCOMING TEST FAILURE IS THE BROKEN SOLDER CONNECTIONS. THE ROOT CAUSE OF THE BROKEN SOLDER CONNECTIONS CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED MONITOR SN (B)(4) TO REPORT THAT THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662129 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRIILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA